Melatonin

Product NDC: 43857-0511
11-digit product format: 438570511
Labeler code: 43857
Product ID: 43857-0511_adcac0e0-d21f-4124-b951-e6913591ac9f
Type: HUMAN OTC DRUG
Nonproprietary name: Melatonin
Dosage form: LIQUID
Route: ORAL
Labeler: BioActive Nutritional, Inc.
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2019-03-22
Substance: MELATONIN
Active strength: 6 [hp_X]/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Melatonin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MELATONIN	6 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	JL5DK93RCL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43857-0511-1	2024-10-17	C162847	48780-1	ba0f9c33-43c5-a910-e053-dadaa90a0b85	DRUG FACTS:
43857-0511-1	2021-01-29	C162847	48780-1	ba0f9c33-43c5-a910-e053-dadaa90a0b85	DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43857-0511-1	Melatonin	30 mL in 1 BOTTLE, DROPPER	LIQUID	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43857-0511	MELATONIN LIQUID [BIOACTIVE NUTRITIONAL, INC.]	2	Current NDC, Legacy NDC, 1 package rows	20241019_8951e5e9-5d8f-4808-b247-208760fae656.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
43857-0511-1	43857051101	30 mL in 1 BOTTLE, DROPPER (43857-0511-1)	30 ml	2019-03-22	No	No	Historical